Automated implantable penile prosthesis pump system

ABSTRACT

An implantable penile prosthesis having an inflatable cylinder with at least one piezoelectric pump for transferring fluid between an integrated reservoir and pressure chamber within the inflatable cylinder. The piezoelectric pump includes an actuator powered by an inductor coil integrated into the inflatable cylinder allowing for wireless control of the inflation and deflation of the inflatable cylinder. An external control system having a corresponding inductive coil can be used to supply a magnetic field for creating a current in the inductor coil integrated into the inflatable cylinder.

RELATED APPLICATION

The present application claims the benefit of U.S. ProvisionalApplication No. 61/588,917 filed Jan. 20, 2012, which is incorporatedherein in its entirety by reference.

FIELD OF THE INVENTION

The present invention is directed a system for inflating at least oneinflatable cylinder of an implantable penile prosthesis. Specifically,the present invention is directed an automated pumping system forinflating the inflatable cylinder.

BACKGROUND OF THE INVENTION

Implantation of an implantable penile prosthesis (IPP) is a commonsurgical procedure for treating erectile dysfunction and other penileailments. Typically, an IPP comprises at least one inflatable cylinderconnected via kink resistant tubing to a pump with an integratedreservoir containing a quantity of fill liquid. In other versions, anIPP can alternatively comprise an inflatable cylinder connected by apump to a separate reservoir for holding the quantity of fill liquid.Commercial IPP devices are available under the trade names AMBICOR andAMS 700 from American Medical Systems of Minnetonka, Minn. Typically,the entire IPP is implanted into the patient's body with the inflatablecylinder being placed in the corpus cavernosum and the pump being placedwithin the scrotum. The reservoir can also be placed within the scrotumor placed elsewhere within the pelvic region. To operate the IPP, thepump is manually actuated to transfer fill liquid from the integrated orimplanted reservoir into the inflatable cylinder to fill and pressurizethe inflatable cylinder.

While fully implanting the IPP within the body provides numerousadvantages, operating the IPP is inherently more difficult due to thelack of direct access to the IPP. In particular, because the pump mustbe manually actuated through the scrotum, locating and operating thepump can be difficult. In addition, the position of the pump may causethe patient's to experience discomfort when operating the pump. An addeddrawback is that patients with comorbidities affecting their dexteritymay be completely unable to operate the pump.

In addition to the practical difficulties of fully implanting the IPP,the implantation and positioning of the various components of the IPPitself can be a deterrent to those considering implanting an IPP. Theimplantation of an IPP requires an extensive surgical procedureinvolving not only the positioning of the inflatable cylinders, but alsothe implantation of the pump and the reservoir. The extensive surgicalprocedure for implanting an IPP can be a significant deterrent to thoseconsidering the implantation of the IPP.

SUMMARY OF THE INVENTION

The present invention is directed to an IPP having an inflatablecylinder comprising an integrated inflation system for inflating andpressurizing the inflatable cylinder. The inflation system comprises apiezoelectric pump for drawing fluid from a reservoir integrated intothe inflatable cylinder and feeding the fluid into a pressure cylinderto expand and stiffen the inflatable cylinder. The piezoelectric pumpand reservoir can be fully contained within the inflatable cylindersignificantly reducing the extent and complexity of the surgery requiredfor implanting the IPP. In addition, the automated piezoelectric pumpreplaces the manually operated mechanical pump used to inflate theinflatable cylinder in conventional IPP allowing for more preciseinflation and pressurization of the pressure cylinder. The piezoelectricpump can be wirelessly controlled to control the inflation or deflationof the pressure cylinder.

An IPP, according to an embodiment of the present invention, comprises apressure cylinder and an inflation system having a piezoelectric pumpand an integrated reservoir. The piezoelectric pump comprises at leastone piezoelectric actuator operably linked to a pump inductive coil. Thepump inductive coil can be exposed to a magnetic field to create acurrent supplied to each piezoelectric actuator to cause the actuator tomove fluid through the pump.

The piezoelectric pump can be operably linked to the pressure cylinderand can further comprise a first valve for controlling the direction ofthe fluid between the piezoelectric pump and pressure cylinder. Thefirst valve can be actuated between an inflation position in which fluidcan only enter the pressure cylinder for inflating the inflatablecylinder and a deflation position in which fluid can only exit thepressure cylinder for deflating the inflatable cylinder. Similarly, thepump can be operably linked to the integrated reservoir and furthercomprise a second valve controlling the direction of the fluid flowbetween the pump and the reservoir. The first and second valves can beoperably linked such that fluid is transferred from the reservoirthrough the pump to the pressure cylinder and vice versa.

According to an embodiment, the IPP can be provided with an externalcontrol system having a control inductive coil and a power supply. Thecontrol inductive coil can be supplied with an electrical current fromthe power supply to generate a magnetic field for powering the pump whenthe control inductive coil is positioned proximate to the pump inductivecoil. The control system can further comprise control circuitry forcontrolling the magnetic field generated to control the operation of thepump.

A method, according to an embodiment, comprises implanting an inflatablecylinder having an integrated pump powered by a pump inductive coil andadapted to transfer fluid between a pressure cylinder and an integratedreservoir. The method further comprises bringing a control inductivecoil proximate to the pump inductive coil. The method also comprisessupplying an electric current to the control inductive coil to generatea magnetic field for creating a corresponding electrical current in thepump inductive coil to actuate at least one piezoelectric actuator ofthe pump.

The above summary of the various representative embodiments of theinvention is not intended to describe each illustrated embodiment orevery implementation of the invention. Rather, the embodiments arechosen and described so that others skilled in the art can appreciateand understand the principles and practices of the invention. Thefigures in the detailed description that follow more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention can be completely understood in consideration of thefollowing detailed description of various embodiments of the inventionin connection with the accompanying drawings, in which:

FIG. 1 is a partial cross-sectional side view of an implantable penileprosthesis and an external control device according to an embodiment ofthe present invention.

FIG. 2 is a cross-sectional side view of an inflation system for animplantable penile prosthesis according to an embodiment of the presentinvention.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit the invention to theparticular embodiments described. On the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION

As shown in FIG. 1, an implantable penile prosthesis 2 (“IPP”),according to an embodiment of the present invention, comprises at leastone inflatable cylinder 4 implantable within the corpus cavernosum. Eachinflatable cylinder 4 comprises an elongated cylindrical body defining afluid reservoir 6 at one end and an expandable pressure cylinder 8positioned opposite the fluid reservoir 6. Each inflatable cylinder 4further comprises an inflation system 10 operably linking the fluidreservoir 6 to the expandable pressure cylinder 8.

As shown in FIG. 2, the inflation system 10 further comprises at leastone piezoelectric actuator 12 and a pump inductive coil 14. Theinflation system 10 further comprises a first septum 16 defining onewall of the pressure cylinder 8 and a second septum 18 defining one wallof the fluid reservoir 6. The first septum 16 and the second septum 18cooperate to define a pump cavity 20 within the inflatable cylinder 4between the fluid reservoir 6 and the pressure cylinder 8. The firstseptum 16 further comprises a first valve 22 switchable between aninflation position in which fluid can only flow into the pressurecylinder 8 and a deflation position in which fluid can only flow out ofthe pressure cylinder 8. The second septum 16 can further comprise a rod24 extending through the second septum 16 and defining a channel 26providing a fluid communication between the pump cavity 20 and the fluidreservoir 6. The rod 24 is positioned parallel to the longitudinal axisof the inflatable cylinder 4 to provide a guide for the piezoelectricactuators 12 during the movement of the actuators 12. The second septum16 can further comprise a second valve 28 switchable between aninflation position in which fluid can only flow from the fluid reservoir6 and a deflation position in which fluid can only flow into the fluidreservoir 6.

In operation, each of the actuators 12 is positioned on the rod 24 so asto move back and forth axially when supplied with an electrical currentfrom the pump inductive coil 14. The back and forth motion of theactuators 12 draws fluid into the pump cavity 20 from either thereservoir 6 or the pressure cylinder 8 and expels fluid into theopposite chamber. The direction the first and second valves 22, 28 areoriented controls the direction of fluid through the inflation system10. According to an embodiment, first and second valves 22, 28 can bepositioned in a closed orientation to prevent any transfer of fluidbetween the pressure cylinder 8 and fluid reservoir 6.

As depicted in FIG. 1, according to an embodiment, the present inventioncan further comprise an external control system 30 for wirelesscontrolling the operation of the IPP 2. The external control system 30can further comprises a control inductive coil 32 and a power supply 34.The power supply 34 is adapted to supply current to the controlinductive coil 32 to generate a magnetic field for generating acorresponding current in the pump inductive coil 14. According to anembodiment, the control system 30 can further comprise control circuitryfor regulating the current supplied to the control inductive coil 32 tocontrol the operation of the inflation system 10. The control circuitrycan be adapted to pulse the current supplied to the control inductivecoil 32 or automatically start or stop the current. As depicted in FIG.1, the control system 30 can be mounted on a wand 36 allowing the userto position the control inductive coil 32 proximate to the pumpinductive coil 14. According to an embodiment, the wand 36 can furthercomprise a switch 38 allowing a user to manually activate and deactivatethe control inductive coil 32 to control the operation of IPP 2.

A method for inflating an IPP 2 can comprise providing at least oneinflatable cylinder 4 having a fluid reservoir 6 and a pressure cylinder8 with a pump cavity 20 defined there between. The method furthercomprising positioning at least one piezoelectric actuator 12 within thepump cavity 20, wherein each actuator 12 is operably linked to a pumpinductive coil 14. Finally, the method further comprises directing amagnetic field toward the pump inductive coil 14 such that the coil 14generates an electrical current that causes each actuator 12 tomechanically actuated, wherein the movement of the actuator 12 drawsfluid from the fluid reservoir 6 and transfers the fluid to the pressurecylinder 8 to inflate and pressurize the pressure cylinder 8.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and described in detail. It is understood, however, that theintention is not to limit the invention to the particular embodimentsdescribed. On the contrary, the intention is to cover all modifications,equivalents, and alternatives falling within the spirit and scope of theinvention as defined by the appended claims.

The invention claimed is:
 1. An implantable penile prosthesis,comprising: an inflatable cylinder enclosing a fluid reservoir, apiezoelectric pump, a pressure cylinder, a first septum comprising afirst valve fluidly coupling the piezoelectric pump and the pressurecylinder for directing an inflation fluid into and out of the pressurecylinder, a second septum spaced from the first septum and defining areservoir wall of the fluid reservoir, the second septum comprising asecond valve fluidly coupling the piezoelectric pump and the pressurecylinder for directing the inflation fluid into and out of the fluidreservoir, a pump cavity positioned between the first septum and thesecond septum, and a rod extending through the second septum anddefining a channel for fluid communication between the pump cavity andthe fluid reservoir, wherein said piezoelectric pump selectivelytransfers fluid from the fluid reservoir to the pressure cylinder suchthat the inflatable cylinder selectively transitions between a flacciddisposition and an erect disposition.
 2. The implantable penileprosthesis of claim 1, wherein the piezoelectric pump further comprisesan actuator for selectively controlling the piezoelectric pump.
 3. Theimplantable penile prosthesis of claim 2, wherein the actuator isoperably coupled to a cylinder inductive coil, wherein the cylinderinductive coil interacts with a magnetic field to generate current foroperation of the actuator.
 4. The implantable penile prosthesis of claim1, wherein the first valve and the second valve jointly direct flow ofthe inflation fluid between the fluid reservoir and the pressurecylinder.
 5. The implantable penile prosthesis, of claim 1, wherein thefirst septum defines a pressure wall of the pressure cylinder; andwherein the piezoelectric pump is positioned within the pump cavity. 6.The implantable penile prosthesis of claim 1, wherein the first valve ismounted within the first septum and where the second valve is mountedwithin the second septum.
 7. The implantable penile prosthesis of claim1, in combination with an external control system for controllingoperation of the piezoelectric pump.
 8. The combination of claim 7,wherein the external control system comprises a control inductive coiland a power supply, wherein the power supply supplies control current tothe control inductive coil to generates a control magnetic field.
 9. Thecombination of claim 8, wherein the inflatable cylinder further comprisea cylinder inductive coil, wherein the cylinder inductive coil interactswith the control magnetic field to generate a cylinder current.
 10. Thecombination of claim 9, wherein the piezoelectric pump further comprisesa pump actuator and wherein the cylinder inductive coil is operablylinked to the pump actuator, such that the cylinder current selectivelycontrols operation of the piezoelectric pump.
 11. The combination ofclaim 8, wherein the external control system further comprises a controlcircuit for selectively altering the control current.
 12. Thecombination of claim 11, wherein the control circuit comprises a controlswitch for selectively activating and deactivating the generation of thecontrol magnetic field.
 13. The combination of claim 7, wherein theexternal control system comprises a hand held device such that theexternal control system can be positioned in proximity to the inflatablecylinder.
 14. A method for treating erectile dysfunction, comprising:implanting a penile prosthesis within a corpus cavernosum, the penileprosthesis comprising: an inflatable cylinder enclosing a fluidreservoir, a piezoelectric pump, a pressure cylinder, a first septumcomprising a first valve fluid coupling the piezoelectric pump and thepressure cylinder for directing an inflation fluid into and out of thepressure cylinder, a second septum spaced from the first septum anddefining a reservoir wall of the fluid reservoir, the second septumcomprising a second valve fluidly coupling the piezoelectric pump andthe pressure cylinder for directing the inflation fluid into and out ofthe fluid reservoir, a pump cavity positioned between the first septumand the second septum, and a rod extending through the second septum anddefining a channel for fluid communication between the pump cavity andthe fluid reservoir, wherein said piezoelectric pump selectivelytransfers fluid from the fluid reservoir to the pressure cylinder suchthat the inflatable cylinder selectively transitions between a flacciddisposition and an erect disposition; generating a control magneticfield in proximity to the inflatable cylinder; and actuating thepiezoelectric pump within the inflatable cylinder so as to selectivelytransfer an inflation fluid between the fluid reservoir and the pressurecylinder.
 15. The method of claim 14, wherein the step of actuating thepiezoelectric pump, further comprises: generating a pump current with acylinder inductive coil within the inflatable cylinder, wherein the pumpcurrent operably controls a pump actuator linked to piezoelectric pump.16. The method of claim 14, wherein the step of generating the controlmagnetic field in proximity to the inflatable cylinder, furthercomprises: positioning a handheld control system in proximity to theinflatable cylinder.
 17. The method of claim 16, wherein the step ofgenerating the control magnetic field in proximity to the inflatablecylinder, further comprises: directing a control circuit within thehandheld control system to supply a control current from a power supplyto a control inductive coil, said power supply and control inductivecoil being internal to the handheld control system.